ObesityPhase 1NCT06970405
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
A Phase 1 study testing Garetosmab in people with Obesity, run by Regeneron Pharmaceuticals.
Trial summary
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity. The aim of the study is to see how safe and tolerable the study drug is. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Garetosmab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2025to 8 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
- Women must be postmenopausal, as defined in the protocol
- Serum testosterone within age-adjusted normal range for men at screening
- The platelet count is within the normal lower and upper laboratory range
Who cannot join
- Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
- History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
- History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
- Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease
- Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
- Antiplatelet therapy (eg clopidogrel, aspirin), anticoagulants (eg, warfarin, heparin, factor Xa inhibitor, or thrombin inhibitors) in the last 90 days or within 5 half-lives of the therapy at screening, whichever is longer
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- Use in the previous 90 days for >7 consecutive days at screening of anti-obesity medications, anabolic agents, systemic steroids, androgens, estrogens, or progestogens. Chronic stable doses of thyroid hormones in participants with normal thyroid function are allowed
- For women, current use, or past use in the last 90 days at screening of hormonal replacement or contraceptive therapy
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity.
The aim of the study is to see how safe and tolerable the study drug is.
Read more
The study is looking at several other research questions, including:
- How much study drug is in the blood at different times
- What effect the study drug has on the blood clotting
- What effect the study drug has on hormone levels
- What effect the study drug has on some organs that produce hormones
- What effect hormones have on the side effects produced by the study drug
- Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
- Conditions
- Obesity
- Being tested
- Garetosmab, Matching Placebo
- Keywords
- Healthy, Postmenopausal
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaretosmabDrug
Also called REGN2477
Administered per the protocol
Matching PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Experimental | Randomized per the protocol Receives: Drug: Garetosmab |
| Low Dose | Experimental | Randomized per the protocol Receives: Drug: Garetosmab |
| Placebo | Placebo comparator | Randomized per the protocol Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Through Week 32
Severity of TEAEs
Measured: Through Week 32
Secondary outcomes (62)
Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum FSH level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum Luteinizing Hormone (LH) level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum LH level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum total testosterone level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum total testosterone level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum free testosterone level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum free testosterone level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum estradiol level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum estradiol level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum 17-OHP level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum DHEA-S level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum androstenedione level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum androstenedione level in response to GnRH injection
Measured: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection
Measured: Pre-ACTH Baseline, Through Week 20 post-ACTH
Percent change in cortisol level in response to ACTH injection
Measured: Pre-ACTH Baseline, Through Week 20 post-ACTH
Concentrations of garetosmab in serum
Measured: Through Week 32
Concentrations of total activin A in serum
Measured: Through Week 32
Change in bleeding time
Measured: Baseline, At Week 8
Percent change in bleeding time
Measured: Baseline, At Week 8
Change in thrombin time
Measured: Baseline, At Week 8
Percent change in thrombin time
Measured: Baseline, At Week 8
Change in Activated Partial Thromboplastin Time (aPTT)
Measured: Baseline, At Week 8
Percent change in aPTT
Measured: Baseline, At Week 8
Change in Prothrombin Time (PT)
Measured: Baseline, At Week 8
Percent change in PT
Measured: Baseline, At Week 8
Change in International Normalized Ratio (INR)
Measured: Baseline, At Week 8
Percent change in INR
Measured: Baseline, At Week 8
Change in platelets count
Measured: Baseline, At Week 8
Percent change in platelets count
Measured: Baseline, At Week 8
Change in serum ACTH level
Measured: Baseline, Through Week 20
Percent change in serum ACTH level
Measured: Baseline, Through Week 20
Change in serum FSH level
Measured: Baseline, Through Week 20
Percent change in serum FSH level
Measured: Baseline, Through Week 20
Change in serum LH level
Measured: Baseline, Through Week 20
Percent change in serum LH level
Measured: Baseline, Through Week 20
Change in serum Thyroid Stimulating Hormone (TSH) level
Measured: Baseline, Through Week 20
Percent change in serum TSH level
Measured: Baseline, Through Week 20
Change in serum Thyroxine (T4) level
Measured: Baseline, Through Week 20
Percent change in serum T4 level
Measured: Baseline, Through Week 20
Change in serum total testosterone level
Measured: Baseline, Through Week 20
Percent change in serum total testosterone level
Measured: Baseline, Through Week 20
Change in serum free testosterone level
Measured: Baseline, Through Week 20
Percent change in serum free testosterone level
Measured: Baseline, Through Week 20
Change in serum 17-OHP level
Measured: Baseline, Through Week 20
Percent change in serum 17-OHP level
Measured: Baseline, Through Week 20
Change in serum estradiol level
Measured: Baseline, Through Week 20
Percent change in serum estradiol level
Measured: Baseline, Through Week 20
Change in serum DHEA-S level
Measured: Baseline, Through Week 20
Percent change in serum DHEA-S level
Measured: Baseline, Through Week 20
Change in serum androstenedione level
Measured: Baseline, Through Week 20
Percent change in serum androstenedione level
Measured: Baseline, Through Week 20
Change in serum Human Growth Hormone (HGH) level
Measured: Baseline, Through Week 20
Percent change in serum HGH level
Measured: Baseline, Through Week 20
Change in serum Insulin-like Growth Factor (IGF)-1 level
Measured: Baseline, Through Week 20
Percent change in serum IGF-1 level
Measured: Baseline, Through Week 20
Change in serum cortisol level
Measured: Baseline, Through Week 20
Percent change in serum cortisol level
Measured: Baseline, Through Week 20
Incidence of Anti-Drug Antibodies (ADA) to garetosmab
Measured: Through Week 32
Titer of ADA to garetosmab
Measured: Through Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start29 May 2025 (estimated)
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Jun 2026 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970405
- Sponsor's protocol ID
- R2477-OB-2470
- Status last verified
- Sep 2025
- First submitted
- 6 May 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study of Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Garetosmab in Men and Post-Menopausal Women With Obesity Who Are Otherwise Healthy
- ClinicalTrials.gov ID
- NCT06970405
- Acronym / sponsor ID
- R2477-OB-2470
- Conditions
- Obesity
- Keywords
- Healthy, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2025 (estimated)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on otherwise healthy participants with obesity.
The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
- How much study drug is in the blood at different times
- What effect the study drug has on the blood clotting
- What effect the study drug has on hormone levels
- What effect the study drug has on some organs that produce hormones
- What effect hormones have on the side effects produced by the study drug
- Whether the body makes antibodies against the study drug (which could change how well the drug works or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose | Experimental | Drug: GaretosmabRandomized per the protocol |
| Low Dose | Experimental | Drug: GaretosmabRandomized per the protocol |
| Placebo | Placebo comparator | Drug: Matching PlaceboRandomized per the protocol |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with obesity (defined as Body Mass Index (BMI) ≥30 kg/m2) who are otherwise healthy, as defined in the protocol
- Women must be postmenopausal, as defined in the protocol
- Serum testosterone within age-adjusted normal range for men at screening
- The platelet count is within the normal lower and upper laboratory range
Key exclusion criteria (9 listed)
- Patients diagnosed with Type 1 or Type 2 diabetes, as defined in the protocol
- History of any severe, non-traumatic bleeding, and or a known pre-existing medical history of a bleeding, as defined in the protocol
- History of clinically significant cardiovascular (eg, uncontrolled blood pressure), endocrine, respiratory, hepatic, renal, gastrointestinal, hematological, psychiatric, or neurological disease, as defined in the protocol
- Any malignancy in the last 5 years prior to screening visit, except for non-melanoma skin cancer that have been resected with no evidence of metastatic disease
- Any chronic active infection or has received anti-Hepatitis C Virus (HCV) treatments within the previous 6 months, as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaretosmabAlso: REGN2477Administered per the protocol | Drug | High Dose, Low Dose |
| Matching PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through Week 32
Severity of TEAEs
Time frame: Through Week 32
62 secondary outcomes
Change in serum Follicle Stimulating Hormone (FSH) level in response to gonadotropin-releasing hormone (GnRH) injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum FSH level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum Luteinizing Hormone (LH) level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum LH level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum total testosterone level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum total testosterone level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum free testosterone level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum free testosterone level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum estradiol level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum estradiol level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum 17-hydroxyprogesterone (17-OHP) level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum 17-OHP level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum Dehydroepiandrosterone Sulphate (DHEA-S) level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum DHEA-S level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in serum androstenedione level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Percent change in serum androstenedione level in response to GnRH injection
Time frame: Pre-GnRH Baseline, Through Week 20 Post-GnRH
Change in cortisol level in response to Adrenocorticotropic Hormone (ACTH) level injection
Time frame: Pre-ACTH Baseline, Through Week 20 post-ACTH
Percent change in cortisol level in response to ACTH injection
Time frame: Pre-ACTH Baseline, Through Week 20 post-ACTH
Concentrations of garetosmab in serum
Time frame: Through Week 32
Concentrations of total activin A in serum
Time frame: Through Week 32
Change in bleeding time
Time frame: Baseline, At Week 8
Percent change in bleeding time
Time frame: Baseline, At Week 8
Change in thrombin time
Time frame: Baseline, At Week 8
Percent change in thrombin time
Time frame: Baseline, At Week 8
Change in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline, At Week 8
Percent change in aPTT
Time frame: Baseline, At Week 8
Change in Prothrombin Time (PT)
Time frame: Baseline, At Week 8
Percent change in PT
Time frame: Baseline, At Week 8
Change in International Normalized Ratio (INR)
Time frame: Baseline, At Week 8
Percent change in INR
Time frame: Baseline, At Week 8
Change in platelets count
Time frame: Baseline, At Week 8
Percent change in platelets count
Time frame: Baseline, At Week 8
Change in serum ACTH level
Time frame: Baseline, Through Week 20
Percent change in serum ACTH level
Time frame: Baseline, Through Week 20
Change in serum FSH level
Time frame: Baseline, Through Week 20
Percent change in serum FSH level
Time frame: Baseline, Through Week 20
Change in serum LH level
Time frame: Baseline, Through Week 20
Percent change in serum LH level
Time frame: Baseline, Through Week 20
Change in serum Thyroid Stimulating Hormone (TSH) level
Time frame: Baseline, Through Week 20
Percent change in serum TSH level
Time frame: Baseline, Through Week 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Garetosmab in people with Obesity, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Through Week 32). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.